STATES PRESSURE FDA FOR GENERIC INSULIN

Mississippi Gov Haley Barbour is leading
a group of officials from 11 states in a
drive to secure marketing approval for a
cost-saving generic version of insulin.
Patients and taxpayers spend $3.3 billion
a year on insulin to treat diabetes, and
access to generic insulin could reduce
those costs by $1 billion or more annually.
Much of those savings would accrue to
financially pressed state Medicaid programs,
which currently spend $500 million
annually on insulin.

The holdup is at the FDA, where officials
have failed to follow through on
promises made 6 years ago to issue
guidelines for the approval of generic
insulin and generic human growth hormone.

Barbour and 10 other state governors
from across the country are putting political
pressure on the FDA to clear a path
for the introduction of generic insulin
products. "To have a lower-cost solution
for our very large diabetic population is in
the interest of the state and the interest
of these people," Barbour said. The governors
are seeking FDA guidelines explaining the testing and documentation
that would be required for the approval of insulin, a step that generic drug manufacturers
consider a prerequisite to submitting applications for insulin products.